Self-Management Interventions After an ICD Shock

Biobehavioral Intervention to Reduce PTSD After ICD Shock

This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.

Study Overview

• Status: Recruiting
• Conditions: Implantable Defibrillator User; Stress Reaction; Ptsd; Stress Management; Social Cognitive Theory
• Intervention / Treatment: Behavioral: Self-Paced Self-Management (SPSM)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia M Dougherty, ARNP, PhD; Phone Number: 206 221-7927; Email: cindyd@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Cynthia Dougherty, ARNP, PhD; Phone Number: 206-221-7927; Email: cindyd@u.washington.edu
      • Principal Investigator: Cynthia Dougherty, ARNP, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),
2. receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;
3. able to read, speak and write English;
4. access to online resources and telephone for study duration.

Exclusion Criteria:

1. current diagnosis of PTSD, schizophrenia or bipolar disorder;
2. Short BLESSED score >6 indicating cognitive dysfunction [73];
3. age <18 years;
4. AUDIT-C score ≥4 for alcohol use;
5. regular non-medical use of illicit drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPSM intervention; Heart rate self monitoring Online shock management modules	Behavioral: Self-Paced Self-Management (SPSM); (SPSM) consists of two components: 1) HR Self-monitoring, and 2) online Shock Management modules (N=4) with weekly telephone coaching, completed over 1 month.
No Intervention: usual care; standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICD Shock anxiety	Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.	Baseline, 1, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total daily physical activity(steps/day)	Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.	Baseline, 1, 6 months
Depression	PHQ-9, 0-27. Higher is higher depression.	Baseline, 1, 6 months
PTSD Symptoms	Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms	Baseline, 1, 6 months
Quality of Life-Physical and Mental	PROMIS Global v 2.0, 0-50. Higher is higher qol.	Baseline, 1, 6 months
Outcome expectation, 0-90. Higher is higher OE.	OE Scale	Baseline, 1, 6 months
Salivary cortisol	Cortisol in saliva, the range in humans varies. measured in pg/ml.	Baseline, 1, 6 months
Acceptability	Acceptability of interventions and materials measured in terms of patient burden (time to complete questionnaires & data collection, ease in understanding, implementing the intervention). These are qualitative open ended answers to questions and do not produce a number.	6 months
Self-Efficacy Expectations	Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy	Baseline, 1, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing the intervention (composite outcome)	Feasibility will be measured using patient recruitment and contact rates (reach within 1-3 days of shock, number screened, eligible & enrolled, proportion eligible vs agree to participate). Each of these variables creates a number for the total study. They elements are added together to get a score.	6 months
Safety (composite outcome) of the intervention	Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no. Each outcome is score and the total number is summarized.	2 years of the trial
Acceptability of the intervention (composite outcome)	Acceptability of interventions and materials measured in terms of patient burden (time to complete questionnaires & data collection, ease in understanding, implementing the intervention). These are qualitative open ended answers to questions and do not produce a number.	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR); East Carolina University
• Investigators: Principal Investigator: Cynthia M Dougherty, ARNP, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: implantable cardioverter defibrillator; stress management; ptsd
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Wounds and Injuries; Fractures, Bone; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Fractures, Stress
• Other Study ID Numbers: STUDY00007840; 1R21NR020967-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To support efforts by other researchers in replicating this study, and clinicians and healthcare systems to implement the interventions, we will 1) share the detailed study protocol, patient provider intervention materials, measures, and tools; 2) share a de-identified dataset.
• IPD Sharing Time Frame: 1 year after trial completion, available for up to 5 years after trial completion
• IPD Sharing Access Criteria: Contact PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No